Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Myeloid, Chronic, BCR-ABL Positive
Both
Leukemia, Myeloid, Chronic, BCR-ABL Positive
Trial Information
Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.
Inclusion Criteria:
- CML patients with failure or suboptimal response to imatinib therapy according to
criteria established by the European Leukemia Net (ELN)
- Patients with grade II or higher adverse events.
- CML patients not suitable for stem cell transplantation.
Exclusion Criteria:
- Patients in blast crisis.
- Pregnant women
- Patients without a contraception method.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Major molecular response
Outcome Description:
Major molecular response will be evaluated with quantitative Real time polymerase chain reaction assay (RT-PCR)for BCR/ABL at 6 months.
Outcome Time Frame:
6 months
Safety Issue:
No
Authority:
Mexico: Ethics Committee
Study ID:
HE12-019
NCT ID:
NCT01819389
Start Date:
October 2012
Completion Date:
July 2013
Related Keywords:
- Leukemia, Myeloid, Chronic, BCR-ABL Positive
- Chronic myeloid leukemia
- suboptimal response
- imatinib
- nilotinib
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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